The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Ep Navigation System, V1.0 And Accessories.
| Device ID | K090017 |
| 510k Number | K090017 |
| Device Name: | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Balaka Das |
| Correspondent | Balaka Das BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-02 |
| Decision Date | 2009-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835012576 | K090017 | 000 |
| 10846835003796 | K090017 | 000 |
| 10846835003802 | K090017 | 000 |
| 10846835003826 | K090017 | 000 |
| 10846835003857 | K090017 | 000 |
| 10846835003871 | K090017 | 000 |
| 10846835003918 | K090017 | 000 |
| 10846835003925 | K090017 | 000 |
| 10846835008883 | K090017 | 000 |
| 10846835008890 | K090017 | 000 |
| 10846835008906 | K090017 | 000 |
| 10846835008913 | K090017 | 000 |
| 10846835009422 | K090017 | 000 |
| 10846835009439 | K090017 | 000 |
| 10846835003789 | K090017 | 000 |